POLYSTAN HEART LUNG MACHINE SYS— 510(k) K813034

Name: FDA 510(k) clearance K813034
Creator: U.S. Food and Drug Administration
Published: 1981-11-27

Substantially Equivalent

Advocacy International, Ltd.

FDA 510(k) clearance K813034 for POLYSTAN HEART LUNG MACHINE SYS, Substantially Equivalent on 1981-11-27. Applicant: Advocacy International, Ltd.. Device class: 2.

Clearance details

Applicant: Advocacy International, Ltd.
Product code: Code DTQ
Device class: Class 2
Regulation: 21 CFR 870.4220
Advisory panel: Cardiovascular
Date received: 1981-10-28
Decision date: 1981-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.